Healthy volunteers Other
Conditions
Interventions
Test product:
Aceclofenac 100 mg film-coated tablets, Abiogen Pharma S.p.A., Italy
Reference product:
Gladio® 100 mg film-coated tablets, Abiogen Pharma S.p.A., Italy
Each study participant will rec
Sponsors
Abiogen Pharma (Italy)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Informed consent: signed written informed consent before inclusion in the study 2. Sex and Age: men/women, 18-55 years old inclusive 3. Body Mass Index: 18.5-30 kg/m2 inclusive 4. Vital signs: systolic blood pressure 100-139 mmHg, diastolic blood pressure 50-89 mmHg, heart rate 50-99 bpm, measured after 5 min at rest in the sitting position 5. Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the Investigator and to comply with the requirements of the entire study 6. Contraception and fertility (women only): women of child-bearing potential must be using at least one of the following reliable methods of contraception: 6.1. Hormonal oral, implantable, transdermal, or injectable contraceptives for at least 2 months before the screening visit 6.2. A non-hormonal intrauterine device or female condom with spermicide or contraceptive sponge with spermicide or diaphragm with spermicide or cervical cap with spermicide for at least 2 months before the screening visit 6.3. A male sexual partner who agrees to use a male condom with spermicide 6.4. A sterile sexual partner or: True abstinence (i.e., refraining from heterosexual intercourse when this is in line with the preferred and usual lifestyle of the subject). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), lactational amenorrhea, and withdrawal are not acceptable. Women of non-child-bearing potential or in post-menopausal status for at least 1 year will be admitted. For all women, pregnancy test result must be negative at screening and Day -1. 7. Contraception (men only): men will either be sterile or agree to use one of the following approved methods of contraception: 7.1. A male condom with spermicide 7.2. A sterile sexual partner or a partner in post-menopausal status for at least 1 year 7.3. Use by the female sexual partner of a non-hormonal intrauterine device, a female condom with spermicide, a contraceptive sponge with spermicide, a diaphragm with spermicide, a cervical cap with spermicide, or hormonal oral, implantable, transdermal, or injectable contraceptives for at least 2 months before the screening visit or: True abstinence (i.e., refraining from heterosexual intercourse when this is in line with the preferred and usual lifestyle of the subject). Periodic abstinence (e.g., calendar, ovulation, thermal symptoms, post-ovulation methods), female sexual partner lactational amenorrhea, and withdrawal are not acceptable. Men must accept to inform their partners of their participation in the clinical study.
Exclusion criteria
Exclusion criteria: 1. Electrocardiogram (ECG) 12-leads (supine position): clinically significant abnormalities 2. Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study 3. Laboratory analyses: serum alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transpeptidase, total bilirubin and creatine levels exceeding the upper limit of normality, as well as Estimated Glomerular Filtration Rate (eGFR) calculated using the Cockroft-Gault equation and normalized to an average surface area 1.73 m2 1 drink/day for women and >2 drinks/day for men, defined according to the USDA Dietary Guidelines 2020-2025 (9)], caffeine (>5 cups coffee/tea/day) or tobacco abuse (?10 cigarettes/day) 10. Urine drug test: positive result at the drug test at screening or Day-1 11. Alcohol saliva test: positive alcohol saliva test at screening or Day -1 12. Diet: abnormal diets (3500 kcal/day) or substantial changes in eating habits in the 4 weeks before this study; vegetarians 13. Pregnancy (women only): positive or missing pregnancy test at screening or Day -1, pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax and AUC0-t of plasma aceclofenac after single dose administration of test and reference. These parameters will be evaluated analysing venous blood samples collected from participants’ forearm veins at the following times: at pre-dose (0) and 0.5 (30 min), 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8 and 12 h post-dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. tmax, Frel and, if feasible, %AUCextra, AUC0-8, t1/2 and ?Z of plasma aceclofenac after single dose administration of test and reference. These parameters will be evaluated analysing venous blood samples collected from participants’ forearm veins at the following times: at pre-dose (0) and 0.5 (30 min), 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8 and 12 h post-dose. 2. Treatment-emergent adverse events, vital signs (blood pressure, heart rate), physical examinations, body weight, clinical laboratory parameters, and ECG. 3. Vital signs will be evaluated through a sphygmomanometer at each visit. ECG (through an electrocardiograph), visual physical examination, and body weight (through an electronic weighing scale) will be evaluated at screening and final visits. Adverse events will be monitored throughout the whole study course. | — |
Countries
Italy, Switzerland
Contacts
Public ContactMarina Accoto
Outcome results
None listed